Web-Enhanced Guideline Implementation for Post MI CBOC Patients

Not Applicable

Completed

Conditions: Myocardial Infarction
Comorbidity

Registration Number: NCT00126750

Lead Sponsor: US Department of Veterans Affairs

Brief Summary: To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in managing complex patients by providing a single, interactive, and personalized source of information regarding applicable guidelines for post-MI patients. Specifically, 1) the investigators will identify barriers to provider adherence to guidelines within VHA clinics; 2) Apply guideline-based performance measures to electronic medical records (CPRS) and associated administrative data; 3) Implement the interactive Internet intervention developed by the NHLBI study, after inclusion of VA-specific components, including performance feedback for CBOC clinicians; and 4) Test hypotheses on the intervention's effectiveness, sustainability, and cost-effectiveness in both the VA and Medicare populations. This will include a randomized controlled trial with the CBOC as a unit of randomization.

Detailed Description: Some 7.1 million Americans and an estimated 250,000 Veterans actively using VHA are Myocardial Infarction (MI) survivors. To date, most guideline interventions focus on a single patient condition, but ambulatory post-MI patients are frequently more complex, multiple comorbidities, and conflicting guidelines applicable to them. For example, whereas JNC-6 guidelines for the treatment of hypertension suggest pharmacological treatment at blood pressures above 140/80 mm Hg, to be initiated with diuretics or beta-blockers as first line agents, other guidance suggests that for post-MI patients with diabetes, treatment cut-offs should be lower and ACE-inhibitors may be considered as optimal first-line agents. On October 1, 2002, the University of Alabama at Birmingham (UAB) began a study funded by the National Heart, Lung, and Blood institute (NHLBI) as an RO1 (Kiefe, PI (25%), Weissman, co-PI (20%)) to conduct a randomized trial, MI-plus to increase provider adherence to guidelines for post-MI patients. That NHLBI-funded study targets Medicare beneficiaries and their primary care providers in Alabama. Its primary goal is to develop and test with a randomized controlled trial, an Internet-based multimodal guideline implementation strategy. The investigators propose, herewith, to extend and adapt this study to a nationwide sample of VA post-MI patients and their primary care providers in the VA.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 847

Inclusion Criteria

Potential subjects are defined as any VA-employed physician, PA, or CRNP who is a CBOC provider. All such providers will be offered the opportunity to participate and will have the option to agree to participate or not. Performance measure data from records of post-MI patients of the above providers will be extracted to test the experimental intervention. (Note: No individually identifying patient information will be extracted.) All VA-employed CBOC providers (physicians, PAs, CRNPs) will be offered the opportunity to participate in this study. Any subject may refuse to participate or to discontinue participation at will at any point in the study without consequence.

Exclusion Criteria

Potential subjects must be VA-employed physician, PA, or CRNP who is a CBOC provider. No such healthcare providers will be excluded from the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators	1/1/02 - 12/31/08	The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level \< previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level \< previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (\<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (\<8%).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (40): VA Medical Center, Birmingham
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Birmingham, Alabama, United States
Carl T. Hayden VA Medical Center
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Phoenix, Arizona, United States
Fayetteville, AR
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Fayetteville, Arkansas, United States
Long Beach
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Long Beach, California, United States
VA Medical Center
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Nashville, Tennessee, United States
VA Connecticut Health Care System (West Haven)
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West Haven, Connecticut, United States
Bay Pines VA Healthcare System, Pay Pines, FL
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Bay Pines, Florida, United States
VA Medical Center, Miami
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Miami, Florida, United States
VA Medical Center, Decatur
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Decatur, Georgia, United States
Jesse Brown VAMC (WestSide Division)
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Chicago, Illinois, United States
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VA Medical Center, Birmingham
🇺🇸Birmingham, Alabama, United States